TRIFLUOPERAZINE HYDROCHLORIDE tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

TRIFLUOPERAZINE HYDROCHLORIDE (UNII: 6P1Y2SNF5V) (TRIFLUOPERAZINE - UNII:214IZI85K3)

MAH:

Upsher-Smith Laboratories, LLC

INN:

TRIFLUOPERAZINE HYDROCHLORIDE

composition:

TRIFLUOPERAZINE 1 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). When used in the treatment of non-psychotic anxiety, trifluoperazine HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of trifluoperazine HCl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine HCl will be useful in patients with other non-psychotic conditions in

leaflet_short:

Trifluoperazine hydrochloride tablets, USP are available as: 1 mg: Round, film-coated, lavender colored tablets, debossed GG 51 on one side and 1 on the reverse side, and supplied as: NDC 0832-0494-11 bottles of 100 2 mg: Round, film-coated, lavender colored tablets, debossed GG 53 on one side and 2 on the reverse side, and supplied as: NDC 0832-0495-11 bottles of 100 5 mg: Round, film-coated, lavender colored tablets, debossed GG 55 on one side and 5 on the reverse side, and supplied as: NDC 0832-0496-11 bottles of 100 This strength tablet for use only in severe neuropsychiatric conditions. 10 mg: Round, film-coated, lavender colored tablets, debossed GG 58 on one side and 10 on the reverse side, and supplied as: NDC 0832-0497-11 bottles of 100 This strength tablet for use only in severe neuropsychiatric conditions. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN.

authorization_status:

Abbreviated New Drug Application

SPC

TRIFLUOPERAZINE HYDROCHLORIDE- TRIFLUOPERAZINE HYDROCHLORIDE TABLET,
FILM COATED
UPSHER-SMITH LABORATORIES, LLC
----------
TRIFLUOPERAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED
TRIALS (MODAL DURATION OF
10 WEEKS), LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS,
REVEALED A RISK OF DEATH IN
DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF DEATH IN
PLACEBO-TREATED
PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE
RATE OF DEATH IN DRUG-
TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN
THE PLACEBO GROUP.
ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED
TO BE EITHER
CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS
(E.G., PNEUMONIA) IN NATURE.
OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC
DRUGS, TREATMENT WITH
CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO
WHICH THE FINDINGS
OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE ATTRIBUTED TO
THE ANTIPSYCHOTIC DRUG
AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR.
TRIFLUOPERAZINE
HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
(SEE WARNINGS).
DESCRIPTION
Each tablet for oral administration contains trifluoperazine
hydrochloride equivalent to 1 mg, 2 mg, 5
mg, or 10 mg trifluoperazine. The structural formula is:
10-_H_ -PHENOTHIAZINE,
10-[3-(4-METHYL-1-PIPERAZINYL)PROPYL]-2-(TRIFLUOROMETHYL)-,
DIHYDROCHLORIDE.
Inactive ingredients: D & C Red #30 Aluminum Lake, FD & C Blue #2
Aluminum Lake, hydroxypropyl
cellulose, hydroxypropyl methylcellulose, lactose (monohydrate),
magnesium stearate, polyethylene
glycol, povidone, starch (corn), and titanium dioxide.
INDICATIONS AND USAGE
For the management of schizophrenia.
Trifluoperazine HCl is eff